Figure 1
Figure 1. Summary of screening, completion, and withdrawal patient numbers. PP indicates per protocol. The reasons for screening failure (n = 151) were failure to meet inclusion criteria (n = 131) and failure to meet compliance criteria (n = 20). The inclusion criteria failures were: T2* outside of lower limit (n = 18), T2* outside the upper limit and not included in the prevention arm (n = 68), and LVEF outside of limit (n = 6). In addition, 39 patients were screening failures for the cardiac substudy because the sample size had been reached, but they were enrolled in the core EPIC study. The compliance criteria failures were: failed to attend for MR scan, or did not follow instructions (n = 7); failed compliance entry because of alcohol abuse (n = 1); unacceptable laboratory values (n = 10); and did not meet LIC criteria (n = 2), with one patient having LIC of less than 10 mg/kg per day and one patient with a liver mass. The 68 patients who were not included in the prevention arm after screening failed because they did not meet the eligibility criteria for the core EPIC study (unacceptable laboratory values [n = 32], unacceptable test procedure results [n = 12], did not meet diagnostic severity criteria [n = 9], consent withdrawal [n = 1], other [n = 14]). The “other” category comprised resident in Cyprus (n = 1), MR imaging not working (n = 3), noncompliance (n = 2), unfit for cardiac substudy (n = 4), and T2* more than 20 (n = 4, no other information provided).

Summary of screening, completion, and withdrawal patient numbers. PP indicates per protocol. The reasons for screening failure (n = 151) were failure to meet inclusion criteria (n = 131) and failure to meet compliance criteria (n = 20). The inclusion criteria failures were: T2* outside of lower limit (n = 18), T2* outside the upper limit and not included in the prevention arm (n = 68), and LVEF outside of limit (n = 6). In addition, 39 patients were screening failures for the cardiac substudy because the sample size had been reached, but they were enrolled in the core EPIC study. The compliance criteria failures were: failed to attend for MR scan, or did not follow instructions (n = 7); failed compliance entry because of alcohol abuse (n = 1); unacceptable laboratory values (n = 10); and did not meet LIC criteria (n = 2), with one patient having LIC of less than 10 mg/kg per day and one patient with a liver mass. The 68 patients who were not included in the prevention arm after screening failed because they did not meet the eligibility criteria for the core EPIC study (unacceptable laboratory values [n = 32], unacceptable test procedure results [n = 12], did not meet diagnostic severity criteria [n = 9], consent withdrawal [n = 1], other [n = 14]). The “other” category comprised resident in Cyprus (n = 1), MR imaging not working (n = 3), noncompliance (n = 2), unfit for cardiac substudy (n = 4), and T2* more than 20 (n = 4, no other information provided).

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